A clinical trial to evaluate the safety and efficacy of Lycq® on subjects with high serum cholesterol levels

Not Applicable

Completed

• Conditions: Health Condition 1: E780- Pure hypercholesterolemia

• Registration Number: CTRI/2013/06/003786
• Lead Sponsor: Edio Healthcare AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-12-29
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

•Healthy as assessed by screening laboratory tests

•Age 25 to 70

•Total serum cholesterol level > 5.2 mmol/l, <7.0 mmol/

•Normal liver, kidney and thyroid function

•Signed written informed consent

Exclusion Criteria

•Participation in a clinical study 30 days prior to screening visit

•Established /diagnosed phytosterolemia

•Hypersensitivity towards any of the excipients

•Consumption of cholesterol lowering medication 1 month prior to screening visit and throughout the study

•Slimming or medically prescribed diet/prescription to special diet (vegan/gluten-free)

•Alcohol or substance abuse (More than1 to 2 Drinks for Female and 2to 4 drinks for Males per day), within 6 months prior to or under the study.

•History of unstable coronary artery disease within the previous 6 months

•Transient Ischemic Attack (TIA) within 1 year prior to screening

•Diabetes

•Hyper-/hypo-thyroidism

•Malignant disease, treatment ended less than 12 months prior to study start.

•Pregnant or attempting to become pregnant or lactating during any period of the study

•Lack of suitability for participation in the trial, for any reason, as judged by staff at the Investigating party

Study & Design

• Study Type: Interventional
• Study Design: Not specified